MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number B35200

Device Problems Intermittent Continuity (1121); Disconnection (1171); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Unintended Collision (1429)

Patient Problem Shaking/Tremors (2515)

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer that reported ever since the patient fell on (b)(6) 2023 the neurostimulator shtus itself off at random for no reason and sometimes it will shut off in the middle of the night.The consumer stated, "if he moves his arm, it shuts itself off." the patient shakes all the time when the ins is turned off, and they have to "wrap him together so he can't move." according to the consumer someone at the physician¿s office said there is nothing wrong with the patient's ins.The consumer also mentioned the ins moved when the patient fell, and the communicator began to have issues communicating with the ins.The consumer thought the communicator has had issues communicating with the patient's ins because they believe one of the implanted wires came loose from the ins when the patient fell.This morning, the patient was shaking like crazy while they were eating breakfast and thought the ins was turned off.The consumer tried to check if the ins was off, but they were unable because the communicator was not communicating with the ins.The communicator indicator lights were flashing green and blue continuously.The consumer held down the power button on the communicator until the lights stopped flashing.The communicator powered on normally after that, and they were able to pair the communicator to the handset by scanning the qr code.The consumer confirmed the communicator communicated with the ins, but they did not say whether the ins was turned on or off and therapy status was not obtained due to the consumer ending the call.

• Brand Name: PERCEPT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17815902
• MDR Text Key: 324216395
• Report Number: 3004209178-2023-16483
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000519216
• UDI-Public: 00763000519216
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2024
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 09/26/2023
• Date Device Manufactured: 04/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male